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Sinovac Biotech Begins Phase II Test of Bird Flu Vaccine
Posted on Jun 11th, 2007 with stocks: SVA
ChinaBio Today submits: Sinovac Biotech (SVA), a Beijing-based biotech that specializes in vaccines, announced that the Chinese government gave the company the go-ahead to begin Phase II trials of Panflu, its avian flu vaccine. In 2006, the company successfully completed a Phase I trial of the vaccine.
In the Phase I trial, two doses of the vaccine produced an immune response of sufficient quality to meet European standards for licensing a non-pandemic flu vaccine. Results were published in the on-line version of the British medical publication The Lancet.
The Chinese government pledged $2.7 million to help Sinovac build a manufacturing facility for its already-approved seasonal flu vaccine. This facility could easily be converted into an avian flu manufacturing plant if the vaccine continues to show promise. Reportedly, the facility will have the capability to produce 20 million doses of the vaccine annually.
Sinovac intends to begin producing avian flu vaccine before it has official state approval. It figures that governments will stockpile the vaccine as a stopgap measure, in case the worrisome virus ever develops the ability to transmit itself from one human to another ? the doomsday scenario that would presage a pandemic.
After all, a government could spend a relatively paltry amount (say $50 million) for a large number of doses, just to be able to say it is doing something to protect its population in case of a pandemic. That kind of money would mean a lot to Sinovac, which ended 2006 slightly in the red on just $15 million of revenue.
Plus, the Chinese government is underwriting the cost of the research for the avian flu vaccine. It is not asking for any ownership rights as compensation for either the research or the manufacturing support.
In the Phase I trial, 120 patients were given a two-dose regimen of 30 micrograms of Panflu, which was administered along with an adjuvant. The vaccine contained a modified version of the whole H5N1 virus. The use of a whole virion vaccine, as opposed to a split-virion vaccine, lowers the amount of antigen needed to produce a sufficient response.
In the Phase II trial, Sinovac will conduct (simultaneously) a Phase Ib and Phase II test of the split-virion version of the vaccine alongside the regular Phase II trial of the whole virion vaccine.
Sinovac Biotech Begins Phase II Test of Bird Flu Vaccine
Posted on Jun 11th, 2007 with stocks: SVA
ChinaBio Today submits: Sinovac Biotech (SVA), a Beijing-based biotech that specializes in vaccines, announced that the Chinese government gave the company the go-ahead to begin Phase II trials of Panflu, its avian flu vaccine. In 2006, the company successfully completed a Phase I trial of the vaccine.
In the Phase I trial, two doses of the vaccine produced an immune response of sufficient quality to meet European standards for licensing a non-pandemic flu vaccine. Results were published in the on-line version of the British medical publication The Lancet.
The Chinese government pledged $2.7 million to help Sinovac build a manufacturing facility for its already-approved seasonal flu vaccine. This facility could easily be converted into an avian flu manufacturing plant if the vaccine continues to show promise. Reportedly, the facility will have the capability to produce 20 million doses of the vaccine annually.
Sinovac intends to begin producing avian flu vaccine before it has official state approval. It figures that governments will stockpile the vaccine as a stopgap measure, in case the worrisome virus ever develops the ability to transmit itself from one human to another ? the doomsday scenario that would presage a pandemic.
After all, a government could spend a relatively paltry amount (say $50 million) for a large number of doses, just to be able to say it is doing something to protect its population in case of a pandemic. That kind of money would mean a lot to Sinovac, which ended 2006 slightly in the red on just $15 million of revenue.
Plus, the Chinese government is underwriting the cost of the research for the avian flu vaccine. It is not asking for any ownership rights as compensation for either the research or the manufacturing support.
In the Phase I trial, 120 patients were given a two-dose regimen of 30 micrograms of Panflu, which was administered along with an adjuvant. The vaccine contained a modified version of the whole H5N1 virus. The use of a whole virion vaccine, as opposed to a split-virion vaccine, lowers the amount of antigen needed to produce a sufficient response.
In the Phase II trial, Sinovac will conduct (simultaneously) a Phase Ib and Phase II test of the split-virion version of the vaccine alongside the regular Phase II trial of the whole virion vaccine.
